Drug recall
Corneal tissue. ''Rocky Mountain Lions Eye Bank***Single Patient Use Only***Do Not Freeze***Tissue is not…
FDA recall event 25068 · Class II · Rocky Mountain Lions Eye Bank
Key facts
| Event ID | 25068 |
|---|---|
| Recall numbers | B-0304-3 |
| Recalling firm | Rocky Mountain Lions Eye Bank |
| Product type | Biologics |
| Products | Corneal tissue. ''Rocky Mountain Lions Eye Bank***Single Patient Use Only***Do Not Freeze***Tissue is not sterile***02-0954-100***Cornea in Optisol-GS***FDA approved tests***Neg***''., Corneal tissue. ''Rocky Mountain Lions Eye Bank***Single Patient Use Only***Do Not Freeze***Tissue is not sterile***02-0954-200***Cornea in Optisol-GS***FDA approved tests***Neg***''. |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Human tissue for transplantation was incorrectly tested for viral markers in that the blood sample used for testing was likely hemodiluted, Human Tissue for Transplantation, was incorrectly tested for viral markers in that the blood sample used for testing was likely hemodiluted |
| Initiation date | Oct 31, 2002 |
| City | Aurora |
| Country | United States |
| FEI number | 1000517466 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports